Collapsible valve

ABSTRACT

A collapsible valve comprising a first portion with at least one dimple in a side thereof, and a second portion, the second portion being narrower than the first portion and arranged along an axial dimension of the first portion, the second portion including a cut therein.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation application of, and claimspriority to, U.S. patent application Ser. No. 12/512,719, entitled“COLLAPSIBLE VALVE,” filed on Jul. 30, 2009, the entire contents ofwhich are incorporated by reference herein for all purposes.

TECHNICAL FIELD

The present disclosure relates, generally, to fluid flow devices and,more specifically, to valves for use in medical devices.

BACKGROUND OF THE INVENTION

Needleless access devices allow a healthcare professional to, e.g.,replace/add IV bags, and/or access an IV line without having to use aneedle. FIG. 1 is a cut-away view of a current needleless access device100. Needleless access device 100 includes female luer fitting 101, maleluer fitting 102, and valve 103. When in use, male luer fitting 102 isconnected to, e.g., a catheter or to a female luer, and female luerfitting 101 is connected to a fluid reservoir. Female luer fitting 101is connected to the fluid reservoir via a second male luer fitting (notshown) that includes a hollow member inserted through the top of femaleluer fitting 101, collapsing valve 103 down into volume 104 to break theseal and create a fluid flow path. The hollow member of the second maleluer fitting delivers the fluid, which flows around valve 103 intochannels (not shown) in male luer fitting 102 and into the catheter orfemale luer.

Inside valve 103 is a gap (or septum, not shown), that is filled withair. Device 100 is a positive displacement device, so that when a newconnection is made at female luer fitting 101, device 100 pulls fluid infrom the male side of the valve (i.e., the side proximate male luerfitting 102). When a disconnection is made at female luer fitting 101,device 100 pushes fluid in from the female side (i.e., the sideproximate the top of female luer fitting 101. The advantage of positivedisplacement is that when a disconnection is made, device 100 expelsfluid out of the male luer fitting 102 and effectively flushing thecatheter. By contrast, many devices on the market today have negativedisplacement, so that when a syringe is disconnected, such device pullsa little bit of fluid from the male luer side, which, if a catheter isbeing used, means that blood is pulled into the catheter lumen. Bloodthat is left in a catheter lumen may clot and cause health problems forthe patient.

An additional feature of device 100 is that when the female end isaccessed by a male luer (not shown), valve 103 is elastic so that it canbend out of the way to allow flow and then return to its original shapeafter a disconnection is made at the female end. Thus, device 100re-seals itself and forms a flat surface that can be disinfected at thetop surface 110 using an alcohol swab. By contrast, many devices on themarket use plastic valves that cannot flex to move out of the way toallow flow, thus requiring the use of valves that are slanted orincorporating features at the top, making swabbing difficult.

Device 100 has a symmetrical valve body providing symmetrical wallstrength, as well as weakness points on both sides by virtue ofduckbills 105. Furthermore, device 100 includes uniform wall thicknessin the valve body, even at and around duckbills 105. The contact areabetween a luer and the top surface 110 of valve 103 and the type of luermotion will dictate the form of collapse of the valve body. Device 100provides good performance, but could benefit from enhanced repeatabilityand controllability of collapse.

BRIEF SUMMARY OF THE INVENTION

Various embodiments of the invention are directed to valves, and toneedleless access devices that use collapsible valves, which include acut and at least one dimple to cause specific collapsing valve behavior.In one specific example, a cut is placed on a top portion of a valve,the top portion being narrower in diameter than a bottom portion andforming the top seal of a needleless access device. The bottom portionis substantially cylindrical, forming a septum, and including at leastone dimple thereon. The dimple is angularly offset from the cut byapproximately ninety degrees, enough so that a load point on the topsurface of the valve is shifted away from the cut to delay the collapseof the cut and result in less forward fall of the top portion when thecut collapses. A method according to one embodiment is related toprocesses for manufacture of needleless access devices. Anotherembodiment is directed to a needleless access device that includes acollapsible valve.

The foregoing has outlined rather broadly the features and technicaladvantages of the present invention in order that the detaileddescription of the invention that follows may be better understood.Additional features and advantages of the invention will be describedhereinafter which form the subject of the claims of the invention. Itshould be appreciated by those skilled in the art that the conceptionand specific embodiment disclosed may be readily utilized as a basis formodifying or designing other structures for carrying out the samepurposes of the present invention. It should also be realized by thoseskilled in the art that such equivalent constructions do not depart fromthe spirit and scope of the invention as set forth in the appendedclaims. The novel features which are believed to be characteristic ofthe invention, both as to its organization and method of operation,together with further objects and advantages will be better understoodfrom the following description when considered in connection with theaccompanying figures. It is to be expressly understood, however, thateach of the figures is provided for the purpose of illustration anddescription only and is not intended as a definition of the limits ofthe present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, reference isnow made to the following descriptions taken in conjunction with theaccompanying drawings, in which:

FIG. 1 is a cut-away view of a current needleless access device;

FIGS. 2A and 2B are cut-away views showing an exemplary needlelessaccess device adapted according to one embodiment of the invention;

FIGS. 3A-C show views of a valve by itself;

FIGS. 4A and 4B show views ninety degrees from those of FIGS. 3A and 3B;

FIG. 5 is an illustration of an exemplary needleless access device witha syringe inserted therein and collapsing an exemplary valve;

FIGS. 6A-6D illustrate the behavior of an exemplary valve, as pressureis applied by a syringe, but before collapse, according to embodimentsof the invention;

FIGS. 7A-7D illustrate behavior of an exemplary valve as pressure isapplied by a syringe, but before collapse, according to embodiments ofthe invention;

FIG. 8 is an illustration of one scenario of use of an exemplary valve;and

FIGS. 9A-9C show three examples of a wide variety of cuts that can beapplied to some embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 2A and 2B are cut-away views showing exemplary needleless accessdevice 200 adapted according to one embodiment of the invention. Theview in FIG. 2B is rotated ninety degrees from that shown in FIG. 2A.

Device 200 includes female luer fitting 201, male luer fitting 202, andvalve 210. Valve 210 includes cut 211, which in this example, isreferred to as a “smiley cut.” Valve 210 also includes dimples 212 and213 on the outside of its lower portion and placed with axial andangular offsets from each other so that the body of valve 210 is notsymmetrical. While cut 211 is referred to as a cut, it can bemanufactured using any of a variety of techniques, including molding sothat a cut is not actually made. An example of a material that may beused for male and female luer fittings 201 and 202 is polycarbonate, andan example of a material that may be used for valve 210 is silicone,though any of a variety of suitable materials may also be used invarious embodiments.

Device 200 provides for positive displacement and self sealing, similarto the device shown in FIG. 1. Male luer fitting 202 at the bottom,connects to a catheter or other medical device (not shown) that isconnected to the body of the patient. A syringe (not shown) mates withfemale luer fitting 201 to collapse valve 210 into the cavity definedbetween male and female luer fittings 201 and 202. Fluid flow goes fromthe top of device 200, around valve 210, and through channels 230, 240to middle channel 250 of male luer fitting 202. Valves 260 and 270 allowair to enter and escape septum 215 of valve 210.

When closed, valve 210 provides two seals. The first seal is at the topsurface 280 of device 200. The second seal is at shoulder 290. Asexplained in more detail with respect to FIG. 5, insertion of a syringeat female luer fitting 201 collapses valve 210, thereby breaking theseals. Valve 210 acts as a spring, so that when it is pushed it down, itcollapses, and when the force is removed, it returns to its shapethereby resealing. Generally, the thicker the wall of valve 210, themore spring force, and the thinner the wall, the less spring force.Therefore, wall thickness affects characteristics, such as ease ofsyringe insertion and displacement. In one particular example wherevalve 210 is approximately two centimeters in length, a wall thicknesswithin the range of 0.030 and 0.038 inches provides acceptabledisplacement, sealing, and ease of use. Of course, at dimples 212 and213 the wall thickness is less, as can be seen especially well at FIG.3A.

In one example, device 200 is manufactured by separately molding valve210 and male and female luer fittings 201 and 202. Valve 210 is thenplaced in the cavity that is formed by male and female luer fittings 201and 202. Male and female luer fittings 201 and 202 are positioned andwelded. Device 200 is then sterilized and packaged. Other methods formanufacturing are possible, e.g., by gluing rather than welding male andfemale luers 201 and 202, and are within the scope of embodiments.

FIGS. 3A-C show views of valve 210 by itself. FIG. 3B shows a side view,FIG. 3A shows a cut-away view, and FIG. 3C shows a bottom view of valve210. As can be seen, both the top portion and the bottom portion ofvalve 210 are annular (in this case, substantially cylindricallyshaped), where the top portion includes smiley cut 211, and the bottomportion includes dimples 212 and 213. The bottom portion of valve 210 issubstantially hollow, defining septum 215. FIGS. 4A and 4B show viewsninety degrees from those of FIGS. 3A and 3B.

FIG. 5 is an illustration of exemplary device 200 with exemplary syringe510 inserted therein and collapsing valve 210. Smiley cut 211 collapses,tilting its top surface 216 to let fluid flow out of syringe 510. Thelower portion of valve 210 also collapses, aided by dimples 212 and 213,which act as two weak points, placed to cause the lower portion tocollapse before smiley cut 211 collapses. Arrows are added to FIG. 5 toillustrate a path of fluid as it flows through syringe 510, around valve210, and out of male luer 202.

In the embodiments shown in FIGS. 2-5, smiley cut 211 is placed relativeto dimples 212 and 213 to facilitate specific collapsing behavior. FIGS.6A-6D illustrate the behavior of valve 210, as pressure is applied bysyringe 510, but before collapse. In the embodiment of FIGS. 2-6, dimple213 is placed ninety degrees clockwise from smiley cut 211, which placesload point 610 counterclockwise to smiley cut 211 (wherein clockwise andcounterclockwise refer to the orientation shown in FIGS. 2-6, where thevalve 210 is shown with smiley cut 211 above the dimples). The placementof load point 610 is notable because a male luer fitting (not shown)associated with syringe 510 has a thread to connect to female luerfitting 201, thereby rotating syringe 510 as it is inserted (and inturn, putting rotational pressure on valve 210). As dimple 213 begins tocollapse, pressure point 610 appears ninety degrees from smiley cut 211,where the side of the top portion of valve 210 is stronger than it isdirectly above smiley cut 211. In this embodiment, smiley cut 211collapses later than it would in a scenario where load point 610 isplaced directly over smiley cut 211.

By contrast, FIGS. 7A-7D illustrate behavior of valve 710 as pressure isapplied by syringe 510, but before collapse, according to embodiments ofthe invention. In valve 710, smiley cut 211 is 180 degrees from dimple213 and directly above dimple 212. Such placement of dimples 212, 213and smiley cut 211 causes pressure point 720 to be directly above smileycut 211, thereby causing smiley cut 211 to collapse sooner than it doesin the scenario illustrated in FIGS. 6A-6D.

In many uses, both valve 210 and valve 710 are acceptable alternatives.However, in scenarios wherein syringe 510 includes a counterbore, earlycollapse of smiley cut 211 may cause the top of valve 710 to fallforward and become lodged in the counterbore, thereby somewhat impedingthe flow of fluid. Such a scenario is shown in FIG. 8, where the top ofvalve 710 is lodged in counterbore 820 of syringe 810. By contrast,valve 210 delays the collapse of smiley cut 211, providing a morevertical collapse of smiley cut 211 and avoiding blockage of syringecounterbores. Thus, in scenarios where a syringe includes a counterbore,valve 210 can be employed successfully. Both valve 210 and valve 710 canbe successfully employed in applications using a syringe, such as thatshown in FIGS. 5-7. Various embodiments can use any angular displacementof a dimple relative to a cut, with valve 210 and valve 710 illustratingtwo examples.

While valves 210 and 710 are shown with two dimples each, variousembodiments are not so limited. For instance, more dimples may be added,and some embodiments may include only one dimple. Furthermore,embodiments are not limited to the use of smiley cuts, as other shapedcuts may be employed. For instance, FIGS. 9A-9C show V-cut 910, U-cut920, and “seagull” cut 930, which are but three examples of a widevariety of cuts that can be applied to embodiments.

As shown above, various embodiments include valves with flat tops thatfacilitate flow around, rather than through, said valves. Such featuresprovide advantages over embodiments that use hard plastic, do not haveflat tops, and/or allow flow through, rather than around valves. Forinstance, valves 210 and 710 of the embodiments described above providepositive displacement and are self-flushed, thereby providing betterhygiene that negative displacement devices. Furthermore, the flat topsurfaces of valves 210 and 710 can provide for better swabability thando devices with slanted or grooved tops, once again providing betterhygienic qualities. Additionally, the dimples and cuts shown in theembodiments above provide for somewhat predictable collapse of thevalves, and (especially in the case of valve 210) applicability to anyof a variety of syringes.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions andalterations can be made herein without departing from the spirit andscope of the invention as defined by the appended claims. Moreover, thescope of the present application is not intended to be limited to theparticular embodiments of the process, machine, manufacture, compositionof matter, means, methods and steps described in the specification. Asone of ordinary skill in the art will readily appreciate from thedisclosure of the present invention, processes, machines, manufacture,compositions of matter, means, methods, or steps, presently existing orlater to be developed that perform substantially the same function orachieve substantially the same result as the corresponding embodimentsdescribed herein may be utilized according to the present invention.Accordingly, the appended claims are intended to include within theirscope such processes, machines, manufacture, compositions of matter,means, methods, or steps.

1-18. (canceled)
 19. A needleless access device comprising: a housinghaving an interior cavity; a valve disposed within the interior cavity,the valve comprising: a hollow first portion comprising at least oneside cut; and a second portion fixedly coupled to the first portion, thesecond portion comprising a side cut; wherein the first portion furthercomprises a cavity with a cylindrical wall, the at least one side cutbeing formed in the cylindrical wall, and wherein the first and secondportions each separately collapse when the access device is actuated bya needleless connector such that the valve moves from a sealed positionto an open position, and wherein the first portion collapses before thesecond portion collapses as the needleless connector actuates the accessdevice.
 20. The needleless access device of claim 29, wherein thecylindrical wall of the first portion is straight.
 21. The needlelessaccess device of claim 29, wherein the cylindrical wall has a thicknessthat is selected to cooperate with the at least one side cut to causethe first portion to collapse before the second portion collapses as theneedleless connector actuates the access device.
 22. The needlelessaccess device of claim 29, wherein the cavity of the first portion issealed to the housing to form a liquid space between the housing and thevalve and a separate air space within the cavity of the first portion.23. The needleless access device of claim 32, wherein the air space isvented by a passage through the housing to the outside environment. 24.The needleless access device of claim 32, wherein a volume of the airspace is reduced and a volume of the liquid space increased as the valvemoves from the sealed position to the open position.
 25. The needlelessaccess device of claim 29, wherein the at least one side cut of thefirst portion is at least 90 degrees relative to the side cut of thesecond portion.
 26. The needleless access device of claim 29, wherein noside cut of the first portion is positioned under the side cut of thesecond portion.
 27. The needleless access device of claim 29, whereinthe second portion further comprises a flat surface that is positionedsubstantially flush with an inlet opening in the housing when the valveis in the sealed position and is displaced from the inlet opening whenthe valve is in the open position.
 28. A method of manufacturing aneedleless access device, the method comprising: disposing a collapsiblevalve inside a volume defined by a male fitting and a female fittingsuch that a first portion of the collapsible valve that is proximate thefemale fitting provides a seal at the opening of the female fitting, thecollapsible valve comprising the first portion and a second portionarranged axially with respect to each other, the first portioncomprising a hollow cylinder with a wall, and the second portionincluding a dimple in a side thereof, the dimple radially displaced froma cut on the surface of the first portion such that the first portioncollapses before the second portion collapses when the access device isactuated by a needleless connector.
 29. The method of manufacturing aneedleless access device of claim 38, wherein the surface of the firstportion is approximately 90 degrees from the dimple in the secondportion.
 30. The method of manufacturing a needleless access device ofclaim 38, wherein hollow cylinder of the first portion is sealed to thevolume proximate to the female fitting to form a liquid space betweenthe volume and the collapsible valve and a separate air space within thehollow cylinder of the first portion.
 31. The method of manufacturing aneedleless access device of claim 38, wherein the air space is vented bya passage through the volume to the outside environment.
 32. The methodof manufacturing a needleless access device of claim 38, wherein avolume of the air space is reduced and a volume of the liquid spaceincreased as the collapsible valve is actuated by a needlelessconnector.
 33. The method of manufacturing a needleless access device ofclaim 38, wherein the second portion further comprises a flat surfacethat is positioned substantially flush with an inlet opening of thefemale fitting when the collapsible valve is not actuated and isdisplaced from the inlet opening when the valve is in the actuatedposition.
 34. The method of manufacturing a needleless access device ofclaim 38, wherein the cylindrical wall of the first portion is straight.